Athersys Announces Publication of Phase I Data Regarding MultiStem(R) for Treating Acute Myocardial Infarction
Clinical Study Published in Circulation Research Demonstrates Safety & Signs of Improvement in Heart Function
CLEVELAND, Nov. 4, 2011 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX) announced the online publication today in Circulation Research of results from a Phase I clinical study that found that the delivery of MultiStem® was safe and well tolerated in patients who had recently suffered an acute myocardial infarction (AMI). The data also suggest improved cardiovascular performance, particularly among patients with severely compromised heart function.
"We are pleased to publish these results in the highly regarded journal, Circulation Research. We believe this reflects the relevance of the study findings, and illustrates the potential for MultiStem in the cardiovascular area," stated Gil Van Bokkelen, Chairman & CEO of Athersys, Inc. "Based on these results we are continuing our plans to initiate a Phase II clinical trial that will evaluate the efficacy of MultiStem in AMI."
The Phase I clinical trial was conducted at 7 centers in the United States including the Cleveland Clinic, New York Presbyterian Hospital and Henry Ford Medical Center. The objective of the trial was to evaluate the safety of MultiStem administered by catheter delivery into the heart of patients that had recently suffered an AMI, resulting in severely compromised heart function.
"This is the first clinical study to date with cell therapy that replicates the significant improvements in heart function observed in animal models of AMI," said first author and co-Principal Investigator of the study Dr. Marc Penn, Director of Research at Summa Cardiovascular Institute and Northeast Ohio Medical University. "These results provide an important basis for understanding the properties of MultiStem in AMI, and we look forward to participating in the Phase II clinical trial to substantiate these results."
Data from the study demonstrate that delivery of MultiStem appeared safe, and did not result in any clinically significant changes in vital signs, allergic reactions, or infusion-related toxicities. In addition, there were no cellular or humoral immune responses observed up to 4 months after MultiStem injection. Following treatment, patients who exhibited significant myocardial damage and received ≥50 million cells demonstrated strong trends for improvement in both ejection fraction and left ventricular stroke volume during the follow-up period. Based on historical results, these measures are believed to correlate with improved clinical outcomes.
Previously published preclinical studies of MultiStem have shown that administration of a single dose of MultiStem can convey therapeutic benefits through multiple distinct mechanisms, such as protecting and preserving at risk tissue in the heart, reducing inflammation, and promoting revascularization over time. These studies also show improvement in cardiac function and increased capillary density in the heart in both rodent and porcine models of AMI.
"This study validates the combination of an off the shelf stem cell product and a catheter delivery system, both quite novel for this clinical purpose," said senior author and co-PI of the study Dr. Warren Sherman, Director of Stem Cell Research at Columbia University Medical Center's Center for Interventional Vascular Therapy. "The potential to repair injured regions of heart tissue by using this target-specific approach is most encouraging, and builds on previous studies with MultiStem. Its therapeutic benefit would complement and enhance current standards of care."
Acute myocardial infarction is a leading cause of morbidity and mortality worldwide. A myocardial infarction occurs when the blood supply to the heart is interrupted or diminished, leading to ischemic myocardial tissue. Myocardial infarction is the leading cause of death in the United States, with more than 1.25 million individuals suffering a heart attack each year.
MultiStem is a patented and proprietary cell therapy product consisting of a special class of stem cells that are obtained from the bone marrow or other tissue sources of healthy, consenting adult donors, and which have the demonstrated ability to produce a range of factors, as well as form multiple cell types. MultiStem appears to promote tissue repair and healing in a variety of ways, such as through the production of multiple therapeutic factors produced in response to signals of inflammation and tissue damage. Athersys believes that MultiStem represents a unique "off-the-shelf" stem cell product based on work that demonstrates the ability to deliver multiple mechanisms of therapeutic benefit, administration of the product without tissue matching or immunosuppression, and its capacity for large-scale production. Athersys has forged strategic partnerships with Pfizer Inc. to develop MultiStem for inflammatory bowel disease and with Angiotech to develop MultiStem in acute myocardial infarction and other cardiovascular indications.
Athersys is a clinical stage biopharmaceutical company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The Company is developing MultiStem®, a patented, adult-derived "off-the-shelf" stem cell product platform for multiple disease indications, including damage caused by myocardial infarction, bone marrow transplantation and oncology treatment support, ischemic stroke, and inflammatory bowel disease. The Company is also developing a portfolio of other therapeutic programs, including orally active pharmaceutical product candidates for the treatment of metabolic and central nervous system disorders, utilizing proprietary technologies, including Random Activation of Gene Expression (RAGE®). Athersys has forged several key strategic alliances and collaborations with leading pharmaceutical and biotechnology companies, as well as world-renowned research institutions in the United States and Europe to further develop its platform and products. More information is available at www.athersys.com.
The Athersys, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=4548
CONTACT: William (B.J.) Lehmann, J.D.
President and Chief Operating Officer
Tel: (216) 431-9900
Lisa M. Wilson
Tel: (917) 543-9932
Source: Athersys, Inc.
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